Is medical research the new imperialism

... a kind, forgiving, charitable, pleasant time; the only time I know of, in the long calendar of the year, when men and women seem by one consent to open their shut-up hearts freely, and to think of people below them as if they really were fellow-passengers to the grave, and not another race of creatures bound on other journeys.

(Charles Dickens, A Christmas Carol)

Tomorrow's medicine is today's research. That is why the question of how we allocate resources to research is at least as important as the question of how we allocate resources to health care itself. But this is not a question that you will find has been the focus of much ethical discussion. Most discussion about the ethics of medical research addresses the question of how research should be regulated. Indeed, medical research is in many ways much more strictly regulated than medical practice. From a perusal of the innumerable guidelines on medical research you could be forgiven for thinking that medical research, like smoking, must be bad for your health; that in a liberal society, since it cannot be altogether banned, strict regulation is needed to minimize the harm that it can do.

The reason for this strict control lies in history. The appalling experiments carried out by some Nazi doctors led, in 1946, to the

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24. From reading the many guidelines you might think that medical research, like smoking, must be bad for your health.

first internationally agreed guidelines on medical research involving people - the Nuremberg Code. This code consisted of ten principles and these were incorporated by the medical profession into the Declaration of Helsinki, which was first published by the World Medical Association in 1964 and last updated in 2000. The Declaration of Helsinki has many offspring of varying legitimacy in the form of guidelines for medical research. These guidelines highlight four main issues: respect for the autonomy of the potential participants in research; the risk of harm; the value and quality of the research; and aspects ofjustice.

25. Competent adults can take risks in order to enjoy paragliding, but are not allowed to take comparable risks in order to help with medical research. Isn't this an infringement of our basic liberties?

The position taken on the risk of harm is rather interesting. Guidelines agree that research participants should not be put at more than 'minimal risk of harm'. This is the case even if the participant is a competent adult fully informed about the risks and benefits and who voluntarily agrees to take part. Although it is not entirely clear what is meant by minimal harm, it seems to be set at a level taken by somewhat risk-averse people in their normal lives. In other words the guidelines are highly paternalistic.

Why should risk of harm be more carefully controlled, and more restrictive, in the context of medical research, than it is in other areas of our lives? We do not prevent the sale or purchase of skis, motorbikes, or hang-gliders, although these expose purchasers to moderate risks. Why should the control of medical research be different?

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